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Status:
US Approved Rx
(2024)
Source:
NDA217900
(2024)
Source URL:
First approved in 2024
Source:
NDA217900
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
US Approved Rx
(2024)
Source:
NDA213972
(2024)
Source URL:
First approved in 2024
Source:
NDA213972
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Sulopenem is a thiolanylthiopenem derivative patented by American multinational pharmaceutical corporation Pfizer Inc as an antibiotic with broad-spectrum antibacterial activity against most gram-positive and gram-negative bacteria. Sulopenem showed concentration-dependent bactericidal activities against Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, and Acinetobacter calcoaceticus. Morphological observation using a phase-contrast microscope revealed that sulopenem induced spherical cell formation with E. coli and K. pneumoniae at lower concentrations and bacteriolysis at higher concentrations. Therapeutic efficacies of sulopenem against systemic infections in mice were almost equal to those of imipenem against Streptococcus pneumoniae.
Status:
US Approved Rx
(2024)
Source:
NDA218730
(2024)
Source URL:
First approved in 2024
Source:
NDA218730
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
US Approved Rx
(2024)
Source:
NDA218784
(2024)
Source URL:
First approved in 2024
Source:
NDA218784
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Vorasidenib (also known as AG 881) was developed as an isocitrate dehydrogenase (IDH) type 1 in the cytoplasm and type 2 in the mitochondria, with potential antineoplastic activity. It is known that IDH is an essential enzyme for cellular respiration in the tricarboxylic acid (TCA) cycle. Isocitrate dehydrogenases 1 and 2 (IDH1/2) are homodimeric enzymes that catalyze the conversion of isocitrate to α-ketoglutarate (α-KG) in the tricarboxylic acid cycle. Vorasidenib participated in phase I clinical trials in patients with advanced hematologic malignancies and in gliomas.
Status:
US Approved Rx
(2024)
Source:
NDA218730
(2024)
Source URL:
First approved in 2024
Source:
NDA218730
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
US Approved Rx
(2024)
Source:
NDA218171
(2024)
Source URL:
First approved in 2024
Source:
NDA218171
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
X-396 (Ensartinib) is a novel, potent anaplastic lymphoma kinase (ALK) small molecule tyrosine kinase inhibitor (TKI) with additional activity against MET, ABL, Axl, EPHA2, LTK, ROS1 and SLK. Ensartinib has demonstrated activity in ALK treatment naïve and previously treated patients and has a generally well tolerated safety profile. Ensartinib is currently in a global phase 3 trial in ALK positive non-small cell lung cancer (NSCLC) patients. The phase 1/2 clinical findings support the preclinical results that the use of ensartinib may result in favorable therapeutic outcomes in patients with ALK NSCLC, including patients with CNS metastases. In this study, ensartinib was generally well tolerated with the most common adverse event being a rash.
Status:
US Approved Rx
(2024)
Source:
NDA218944
(2024)
Source URL:
First approved in 2024
Source:
NDA218944
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
US Approved Rx
(2024)
Source:
NDA219008
(2024)
Source URL:
First approved in 2024
Source:
NDA219008
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
US Approved Rx
(2024)
Source:
NDA218171
(2024)
Source URL:
First approved in 2024
Source:
NDA218171
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
X-396 (Ensartinib) is a novel, potent anaplastic lymphoma kinase (ALK) small molecule tyrosine kinase inhibitor (TKI) with additional activity against MET, ABL, Axl, EPHA2, LTK, ROS1 and SLK. Ensartinib has demonstrated activity in ALK treatment naïve and previously treated patients and has a generally well tolerated safety profile. Ensartinib is currently in a global phase 3 trial in ALK positive non-small cell lung cancer (NSCLC) patients. The phase 1/2 clinical findings support the preclinical results that the use of ensartinib may result in favorable therapeutic outcomes in patients with ALK NSCLC, including patients with CNS metastases. In this study, ensartinib was generally well tolerated with the most common adverse event being a rash.
Status:
US Approved Rx
(2024)
Source:
NDA216540
(2024)
Source URL:
First approved in 2024
Source:
NDA216540
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)